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EVIDENCE

The EVIDENCE* Study

Overview of The EVIDENCE Study

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Data from the EVIDENCE study shows that Rebif® (interferon beta 1-a) 44 mcg three times per week (tiw) works better than Avonex® (interferon beta 1-a) 30 mcg once a week (qw) at preventing relapses at 24 and 48 weeks. These results were seen in patients through the completion of the study — which was an average of 64 weeks.

Patients in the EVIDENCE study were treated for an average of 64 weeks through the completion of the study:

  • Studied the effects of Rebif given by subcutaneous (under the skin) injections at a dose of 44 mcg, three times per week (total weekly dose 132 mcg).
  • Studied against Avonex given by intramuscular injection at a dose of 30 mcg, once a week (total weekly dose 30 mcg).
  • Included 339 people taking Rebif and 338 taking Avonex.

People taking Rebif showed a significant reduction in MRI activity at 24 weeks, 48, and through the completion of the study at an average of 64 weeks.

  • Patients treated with Rebif had fewer active lesions per MRI scan for all activity measures with effects seen within two to three months of starting treatment.
  • More than half (58%) of Rebif patients had no new MRI lesions vs. 38% of patients on Avonex at 64 weeks.
  • Rebif patients had one-third fewer active lesions compared with Avonex patients.

The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.

People taking Rebif 44 mcg tiw were more likely to remain relapse-free than people treated with Avonex 30 mcg qw. This was shown at 24, 48, and through the completion of the study at an average of 64 weeks:

  • 75% of patients who received Rebif did not have a relapse after 24 weeks of treatment compared to 63% of patients treated with Avonex

Side effects were generally similar in those treated with Rebif compared to those treated with Avonex:

  • People taking Rebif had a greater number of injection site reactions (85% Rebif vs. 33% Avonex), increased liver disorders (18% Rebif vs. 10% Avonex), and white blood cell disorders (13.6% Rebif vs. 5.3% Avonex).
  • The majority of side effects for both products were mild and the number of serious side effects was low in both groups.
  • Flu-like symptoms were significantly greater for people taking Avonex than people taking Rebif (53% Avonex vs. 45% Rebif).

Avonex is a registered trademark of Biogen Idec.

 

EVidence for Interferon Dose-response: European North American Comparative Efficacy.

Brought to you by EMD Serono, Inc. and Pfizer Inc., the co-marketers of Rebif® (interferon beta-1a) in the US EMD SeronoPfizer

Prescribing Information - Medication Guide

This information is intended only for residents of the United States.

Rebif is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS. Rebif is not approved for the treatment of chronic progressive multiple sclerosis. Rebif is available by prescription only in 22 mcg and 44 mcg pre-filled syringes and a titration pack.

Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, and blood count or bleeding problems or if you have had previous allergic reactions to medications. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Talk to your doctor before you take any new medicines. Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include depression, liver problems, risk to pregnancy, injection site problems and severe allergic reactions. Allergic reactions are rare and may be associated with difficulty breathing and loss of consciousness, which requires immediate medical attention.

The most common side effects with Rebif are injection site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, increased liver enzymes, and blood cell count decreases. Let your doctor know immediately if you have any of these symptoms or feel sad, tired, hot or cold, experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This information is not intended to replace discussions with your healthcare provider. For additional information about Rebif, please consult the Medication Guide or Prescribing Information and talk to your doctor. You can also call toll free 1-877-44-REBIF (1-877-447-3243). Rebif is available by prescription only.

MS LifeLines is an educational support service for people living with MS and their families. MS LifeLines and MS LifeLines Ambassadors are sponsored by EMD Serono, Inc. and Pfizer Inc.

Rebif, Rebiject II, and MS LifeLines are registered trademarks of EMD Serono, Inc. or its affiliates.

MS in Balance is a service mark of EMD Serono, Inc. or its affiliates.

Copyright 2008 EMD Serono, Inc. All rights reserved.